TY - JOUR
T1 - Validation of a CD30 Enzyme-Linked Immunosorbant Assay for the Rapid Detection of Breast Implant-Associated Anaplastic Large Cell Lymphoma
AU - Hanson, Summer E.
AU - Hassid, Victor J.
AU - Branch-Brooks, Cynthia
AU - Liu, Jun
AU - Kadin, Marshall E.
AU - Miranda, Roberto
AU - Butler, Charles E.
AU - Clemens, Mark W.
N1 - Publisher Copyright:
© 2019 The Aesthetic Society. Reprints and permission: journals.permissions@oup.com.
PY - 2020/1/29
Y1 - 2020/1/29
N2 - Background: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon type of non-Hodgkin lymphoma occurring in the fluid or capsule adjacent to textured breast implants. Diagnosis of BIA-ALCL of symptomatic patients requires demonstration of large anaplastic cells with uniform expression of CD30 protein on immunohistochemistry. Objectives: The authors investigated a novel, rapid, office-based, and economic in-situ enzyme-linked immunosorbent assay (ELISA) for screening BIA-ALCL patients. Methods: A commercially available in-situ ELISA was standardized and validated for patients with confirmed BIA-ALCL diagnosis with clinical isolates. A panel of 9 pathologically confirmed BIA-ALCL patients was screened by serum, plasma, and periprosthetic effusion specimens and compared against serum, plasma, and nonneoplastic delayed seromas in 7 control patients. Statistical analysis demonstrated assay consistency and reliability. Results: All BIA-ALCL effusions demonstrated CD30 ELISA detection at full and all serial concentrations. BIA-ALCL serum specimens and all control specimens were negative at full concentration and serial dilutions (1:100, 1:250, 1:500, and 1:1000). BIA-ALCL plasma specimens were weakly positive at full concentration and revealed no activity with serial dilution. Conclusions: This is the first study to demonstrate a viable alternative to CD30 immunohistochemistry for the screening of BIA-ALCL. Our study demonstrates 100% sensitivity in seroma fluid with no detectable CD30 in benign seroma samples. A CD30 ELISA represents a novel, low-cost screening test, which may be used to screen suspicious aspirations of delayed periprosthetic fluid collections in an office-based setting.
AB - Background: Breast implant-associated anaplastic large cell lymphoma (BIA-ALCL) is an uncommon type of non-Hodgkin lymphoma occurring in the fluid or capsule adjacent to textured breast implants. Diagnosis of BIA-ALCL of symptomatic patients requires demonstration of large anaplastic cells with uniform expression of CD30 protein on immunohistochemistry. Objectives: The authors investigated a novel, rapid, office-based, and economic in-situ enzyme-linked immunosorbent assay (ELISA) for screening BIA-ALCL patients. Methods: A commercially available in-situ ELISA was standardized and validated for patients with confirmed BIA-ALCL diagnosis with clinical isolates. A panel of 9 pathologically confirmed BIA-ALCL patients was screened by serum, plasma, and periprosthetic effusion specimens and compared against serum, plasma, and nonneoplastic delayed seromas in 7 control patients. Statistical analysis demonstrated assay consistency and reliability. Results: All BIA-ALCL effusions demonstrated CD30 ELISA detection at full and all serial concentrations. BIA-ALCL serum specimens and all control specimens were negative at full concentration and serial dilutions (1:100, 1:250, 1:500, and 1:1000). BIA-ALCL plasma specimens were weakly positive at full concentration and revealed no activity with serial dilution. Conclusions: This is the first study to demonstrate a viable alternative to CD30 immunohistochemistry for the screening of BIA-ALCL. Our study demonstrates 100% sensitivity in seroma fluid with no detectable CD30 in benign seroma samples. A CD30 ELISA represents a novel, low-cost screening test, which may be used to screen suspicious aspirations of delayed periprosthetic fluid collections in an office-based setting.
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U2 - 10.1093/asj/sjy327
DO - 10.1093/asj/sjy327
M3 - Article
C2 - 30789639
AN - SCOPUS:85078688438
SN - 1090-820X
VL - 40
SP - 149
EP - 153
JO - Aesthetic surgery journal
JF - Aesthetic surgery journal
IS - 2
ER -